Multicenter phase II trial of gefitinib first-line therapy followed by chemotherapy in advanced non-small-cell lung cancer (NSCLC): SAKK protocol 19/03.

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Serval ID
serval:BIB_A804F229CB56
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Multicenter phase II trial of gefitinib first-line therapy followed by chemotherapy in advanced non-small-cell lung cancer (NSCLC): SAKK protocol 19/03.
Journal
Annals of Oncology
Author(s)
D'Addario G., Rauch D., Stupp R., Pless M., Stahel R., Mach N., Jost L., Widmer L., Tapia C., Bihl M., Mayer M., Ribi K., Lerch S., Bubendorf L., Betticher D.C.
ISSN
1569-8041
Publication state
Published
Issued date
2008
Peer-reviewed
Oui
Volume
19
Number
4
Pages
739-745
Language
english
Notes
Publication types: Clinical Trial, Phase II ; Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't -
Abstract
BACKGROUND: Gefitinib is active in patients with pretreated non-small-cell lung cancer (NSCLC). We evaluated the activity and toxicity of gefitinib first-line treatment in advanced NSCLC followed by chemotherapy at disease progression. PATIENTS AND METHODS: In all, 63 patients with chemotherapy-naive stage IIIB/IV NSCLC received gefitinib 250 mg/day. At disease progression, gefitinib was replaced by cisplatin 80 mg/m(2) on day 1 and gemcitabine 1250 mg/m(2) on days 1, 8 for up to six 3-week cycles. Primary end point was the disease stabilization rate (DSR) after 12 weeks of gefitinib. RESULTS: After 12 weeks of gefitinib, the DSR was 24% and the response rate (RR) was 8%. Median time to progression (TtP) was 2.5 months and median overall survival (OS) 11.5 months. Never smokers (n = 9) had a DSR of 56% and a median OS of 20.2 months; patients with epidermal growth factor receptor (EGFR) mutation (n = 4) had a DSR of 75% and the median OS was not reached after the follow-up of 21.6 months. In all, 41 patients received chemotherapy with an overall RR of 34%, DSR of 71% and median TtP of 6.7 months. CONCLUSIONS: First-line gefitinib monotherapy led to a DSR of 24% at 12 weeks in an unselected patients population. Never smokers and patients with EGFR mutations tend to have a better outcome; hence, further trials in selected patients are warranted.
Keywords
Adult, Aged, Aged, 80 and over, Analysis of Variance, Antineoplastic Agents, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Non-Small-Cell Lung, Cisplatin, Deoxycytidine, Disease Progression, Drug Administration Schedule, Female, Humans, In Situ Hybridization, Fluorescence, Kaplan-Meiers Estimate, Lung Neoplasms, Male, Middle Aged, Mutation, Neoplasm Staging, Protein Kinase Inhibitors, Proto-Oncogene Proteins, Quality of Life, Questionnaires, Quinazolines, Receptor, Epidermal Growth Factor, Risk Assessment, Risk Factors, Smoking, Switzerland, Treatment Outcome, ras Proteins
Pubmed
Web of science
Open Access
Yes
Create date
12/03/2009 13:36
Last modification date
25/09/2019 6:10
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